Effective treatment of many common illnesses requires the administration of medications in a planned and controlled manner. Typically, a physician prescribes a course of treatment for a patient, and the patient is responsible for taking a prescribed medication according to the instructions of the physician. However, many studies have indicated that patients fail to comply with the physician's directives.
For example, a physician may prescribe multiple medications aimed at treating different aspects of an illness. As the number of medications prescribed increases, the responsibility on the part of the patient increases because of different dosages, intervals between dosages, and the like. Noncompliance is especially problematic when the illness being treated is chronic and extended therapeutic regimens are prescribed. However, research has determined that neither the severity of the illness being treated nor the potentially life-threatening consequences related to the patient's failure to follow the course of treatment prescribed by the treating physician significantly improve compliance.
Another problem that has been experienced by prescription drug users is the interaction between medications and/or special requirements that must be met when taking medications. For example, a physician may indicate that the prescribed medications must be taken in a certain order in order to maximize their efficiency with respect to treating specific diseases or disorders. In other cases, a physician may recommend that selected medications be taken with food or water. Other medications may be prescribed to be taken in the absence of alcohol or other intoxicants or medications. All of the directions and warnings must be observed by the patient so that the course of treatment will be safe and effective.
However, research has determined that prescription drug users often fail to comply with the instructions provided by the physician and/or the pharmacist. Many patients either forget to take a specific medication at all or otherwise fail to observe the warnings described above.
Research indicates that several factors appear to affect a patient's compliance with a prescribed course of treatment. These factors include (1) the accessibility of the medication at the prescribed time, (2) the forgetfulness of the patient, (3) the accountability of the patient to a person who is aware of the treatment prescribed and who may monitor the compliance of the patient, (4) the complexity and frequency of medication dosages, (5) prolonged use of the prescribed medication, and (6) the diminution of symptoms produced by the effectiveness of the medication, among other factors.
Patient's noncompliance with a prescribed regimen can lead to several problems. First, the desired effect of treatment may not be obtained. Second, when missing a dose, a patient may attempt to rectify the situation by taking an additional dose. However, a dose taken at the incorrect time and interval could have severe consequences for some drugs. In addition, irregular drug administration could lead to drug resistance. For instance, resistance to antibiotics is a severe problem in treating bacterial infection. Resistance to antiviral drugs has been reported to cause problems in treating HIV-positive patients, due to the fast replication of HIV virus and its ability to become dormant in the human body. The triple cocktail AZT is designed to suppress the generation of multi-resistance if patients follow strictly the drug regimen. However, even in this life-threatening disease, non-compliance is prevalent, and some studies have shown compliance rates as low as 16% (Laws et al. 2000, Taking antiretroviral therapy for HIV infection: learning from patients' stories. J. Gen. Intern. Med. 15(12), 848–858).
Patients generally rely on their memory and/or on manually operated medication dispensers to manage their treatment and their compliance with the instructions provided by the physician. For example, patients may rely on daily dosage pillboxes or similar devices to remind them to take their medication on a daily basis. However, these devices do not generally include any means for determining proper dosage intervals, especially for medications that must be taken more than once a day. Moreover, the devices do not provide any means for alerting a patient to the proper time and/or day for taking the prescribed medication.
Several efforts have been made to produce a device or method to help improve patient compliance with treatment regimens. U.S. Pat. No. 6,529,446 issued on Mar. 4, 2003 and U.S. Pat. No. 6,259,654 issued on Jul. 10, 2001 both to C. de la Huerga disclose a medication organizer with multiple vials secured to a unitary lid. Prescription and medication information is stored in a memory chip attached to the vial, which can be detected by the sensors in the unitary lid. The microprocessor determines the time of medication and reminds the patient with audible and visual alerts and a display, and the compliance information can be stored and communicated remotely. The device requires preparation of separate vials with individual memory chips each time a drug is dispensed by a pharmacist.
Canadian Patent Application No. 2,251,234 published on Dec. 12, 1998 to J. M. Girgis discloses a portable medication reminder and compliance device. The disclosed device contains several medication compartments with a single LCD display providing medication information and messages, and alerting patients at medication times. The compliance data can be stored and communicated remotely. However, the medication compartments either contain no lid, or just a simple cover with no control mechanism. Furthermore, the alert signals must be manually silenced in order to be recorded as an event of compliance.
U.S. Pat. No. 5,850,937 issued on Dec. 22, 1998 to S. J. Rauche discloses a pill dispenser with means to alert users of the time of medication, and the medication compartments are organized by each day of week or each day of month. The device requires input of a personal identification number or PIN for each user at each medication time, and the access of pills requires matching of correct PIN at each of the medication time.
Canadian Patent Application No. 2,212,086 published on Jan. 31, 1998 to H. Ho and A. Chan discloses a medication storage device with the compartments organized in each day of month, and a separate reminder unit providing visual and vibration alerts.
A pill organizer as disclosed in UK Patent No. GB 2,344194 filed on Nov. 25, 1998 by K. Doughty discloses medication compartments organized by multiple periods in a day for 8 days. In one embodiment, the compartments are sealed by film and the puncture of film is recorded as an event of medication compliance.
U.S. Pat. No. 4,617,557 issued on Oct. 14, 1986 to R. E. Gordon discloses a device specially designed for use with a blister package, having alert mechanism. The display is significantly abbreviated due to a limited display area. It reminds the user of the medication time by displaying time to next dose. The blister package needs to be specially prepared for each medication, and a patient may require multiple sets for multiple medications.
U.S. Pat. No. 6,198,383 issued on Mar. 6, 2001 to R. D. Sekura and C. M. Sekura discloses a small medication compliance device for single or multiple medications. The device reminds a user of the time to take medication, and it contains an event switch activated by a user after taking medication. The device is small enough to be attached to medication compartments which are physically separate, and the device further includes a remote programming feature via a wireless link.
Despite previous efforts in the area of medical compliance devices, many of the devices heretofore reported are either cumbersome (e.g., the devices are not portable), expensive, lack desired functionality, or require complicated procedures for programming. Moreover, many prior devices and methods are complicated and difficult to use, especially for patients having diminished physical and mental abilities. Therefore, there is a need for a simple but effective device that will assist a patient in managing their intake of prescription or over-the-counter medications and compliance with prescribed regimens.